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Search / Trial NCT06072976

The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies

Launched by SEATTLE CHILDREN'S HOSPITAL · Oct 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of feeding can affect the health of newborns who have certain gut conditions, like intestinal blockages or specific birth defects. Researchers want to compare the outcomes of feeding these infants an exclusive diet of human milk versus standard feeding practices. The goal is to see which type of feeding helps improve their gut bacteria and how quickly they can start eating fully.

To participate, infants must have certain conditions like gastroschisis or Hirschsprung disease and must be under 6 months old. However, infants who are too premature (born before 34 weeks) or who have had any feedings before the study cannot join. If families choose to participate, they will help researchers learn more about the best feeding methods for these vulnerable babies, which could lead to better care in the future. It's also important to note that while some substances like marijuana might be allowed, others, like certain drugs, are not.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.
  • Exclusion Criteria:
  • 1. Infant has already been on feeds
  • 2. Infants \<34 weeks gestation
  • 3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK)
  • 4. Complicated gastroschisis
  • 5. Short gut syndrome
  • 6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)

About Seattle Children's Hospital

Seattle Children's Hospital is a leading pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital focuses on developing new treatments and therapies that address the unique medical needs of children. With a commitment to excellence, Seattle Children's Hospital collaborates with a network of researchers, healthcare professionals, and academic institutions to ensure rigorous scientific standards and ethical practices in all its clinical investigations. By prioritizing patient safety and scientific integrity, the hospital aims to contribute to the global body of knowledge in pediatric medicine and improve outcomes for children with various health conditions.

Locations

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Katie Strobel, MD

Principal Investigator

Seattle Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported